MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 382637

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth: only the patient's age was provided therefore a default date of birth has been listed.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced leakage.The following information was provided by the initial reporter: used an iv cath on her, initially got good blood return, placement verified by us but the it felt as there was air coming into the cath or a leak.Attemped to make sure all connections were secure, no change.Had to pull this iv and establish another one.Felt this was faulty catheter.Difficult to assess if there was a hole in the catheter as there was blood in the cath.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced leakage.The following information was provided by the initial reporter: used an iv cath on her, initially got good blood return, placement verified by us but the it felt as there was air coming into the cath or a leak.Attemped to make sure all connections were secure, no change.Had to pull this iv and establish another one.Felt this was faulty catheter.Difficult to assess if there was a hole in the catheter as there was blood in the cath.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12310795
• MDR Text Key: 266167208
• Report Number: 1710034-2021-00697
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826378
• UDI-Public: 30382903826378
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 382637
• Device Catalogue Number: 382637
• Device Lot Number: 9305409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR